Study Evaluating Intervention in the Development of Clinical Research in Non-Academic Health Institution (ERNU)

Randomized Trial Evaluating Intervention of the Cancéropôle Nord-Ouest in the Development of Clinical Research in Non-Academic Health Institutions (ERNU)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02765451

Acronym

ERNU

Enrollment

Registered

2016-05-06

Start date

2015-09-30

Completion date

2019-02-21

Last updated

2019-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Clinical Research

Keywords

non-academic, health institution, development, clinical research, cancer, private hospital, public hospital, northwestern france, france, hospitals

Brief summary

This study evaluates the interventions of the Cancéropôle Nord-Ouest in the development of clinical research in non-academic health institution. The randomization, in open label,determines the duration of the interventions. Half of participants will receive the interventions during 2 years, while the other half during 1 year.

Detailed description

French National recommendations ask to increase the accessibility of patients to clinical trials. But this accessibility is far from the optimal care in non-university healthcare institutions (public and private hospital). These non-academic healthcare facilities support at national level about 60% of chemotherapy and 70% of radiotherapy, but only 17% of the inclusions in trials. A dissociation exist between a care package guaranteed on quality criteria (criteria to obtain the capacity to treat the cancers in healthcare institution) distributed all over the country, and the research, mainly concentrated in few referral centers (University hospital and French Comprehensive Cancer Centers). Clinical trials allow patients to have early access to new treatments, optimal and formalized information, and supported by physicians in connection with a strict protocol for patients included. Several studies have shown the existence of geographical and socio-economic determinants for access to reference centers and for the duration of survival of cancer patients. In France, it was found that for patients with gastrointestinal cancer, the remoteness of the place of residence compared to the nearest referral center and a higher level of deprivation decreased the probability of being supported in a reference center. The hypothesis of the ERNU study is that aid from the Cancéropole Nord-Ouest facilitates clinical research activity resulting in a significant development of inclusions in non-university centers of the french north-west inter-region with an influence on the social and geographical inequalities recruitment.

Interventions

BEHAVIORALinterventions of the Cancéropôle Nord-Ouest

During the time defined by the randomization, the Cancéropôle Nord-Ouest offers to help to develop a clinical research activities in the centers. The various aids are : Structuring clinical research at the local level, Support (strategy, logistics, technical, Data management, methodology), a portfolio of straightforward studies ( French National Cancer Institute, cooperative groups conducting cancer clinical research, New Project), Good Clinical Practice training, Clinical research technician, Others,.....

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* French Health institutions of the Basse-Normandie, Haute-Normandie, Nord-Pas-de-Calais and Picardie. * Health institutions non-academic public and private. * Health institutions authorized to treat cancer.

Exclusion criteria

* N/A

Design outcomes

Primary

Measure	Time frame	Description
Number of inclusions in clinical trials of patients	up to 2 years	Measure the increase in inclusions in clinical trials of patients attending a Hospital or a private clinic authorized to treat cancer associated with a support provided by the Cancéropôle Nord-Ouest

Secondary

Measure	Time frame	Description
Reduction of social inequalities recruitment in clinical trials associated with the intervention of the Cancéropôle Nord-Ouest	up to 2 years	assessment of the average of the reduction of social inequalities recruitment in clinical trial before and after the intervention of the Cancéropöle Nord-Ouest in each centers and in global. the social inequalities are calculated with the social and demographic tool developped by the french national institute of statistic and economic studies

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026